Humacyte Q2 2025 Earnings Report

Humacyte EPS Results

• Actual EPS: -$0.24
• Consensus EPS: -$0.15
• Beat/Miss: Missed by -$0.09
• One Year Ago EPS: N/A

Humacyte Revenue Results

• Actual Revenue: $0.30 million
• Expected Revenue: $0.94 million
• Beat/Miss: Missed by -$635.00 thousand
• YoY Revenue Growth: N/A

Humacyte Announcement Details

• Quarter: Q2 2025
• Date: 8/11/2025
• Time: Before Market Opens
• Conference Call Date: Monday, August 11, 2025
• Conference Call Time: 8:00AM ET

Humacyte (NASDAQ:HUMA) engages in the development and manufacture of off-the-shelf, implantable, and bioengineered human tissues for the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. The company using its proprietary and scientific technology platform to engineer and manufacture human acellular vessels (HAVs) to be implanted into patient without inducing a foreign body response or leading to immune rejection. It is developing a portfolio of HAVs, which would target the vascular repair, reconstruction, and replacement market, including vascular trauma; arteriovenous access for hemodialysis; peripheral arterial disease; pediatric heart surgery; and coronary artery bypass grafting, as well as for the delivery of cellular therapy, including pancreatic islet cell transplantation to treat Type 1 diabetes. The company was founded in 2004 and is headquartered in Durham, North Carolina.

Humacyte Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Continued commercial momentum with CIMVEST now VAC‐approved at 82 civilian hospitals (versus 5 last quarter), over 40 more in review, July sales of ~$300K exceeded H1 totals, and the ECAT listing led to the first military facility order.
• Negative Sentiment: The Centers for Medicare & Medicaid Services denied the NTAP application for CIMVEST, citing a lack of unique mechanism, creating a reimbursement headwind in the Medicare trauma segment.
• Positive Sentiment: Strong pipeline progress in dialysis access: Phase III VO7 trial showed significantly improved patency and usability versus fistula in high‐risk patients, VO12 trial has enrolled 100 of 150 patients, with an interim analysis due April 2026 and a planned supplemental BLA filing that year.
• Positive Sentiment: Implemented workforce reductions and spending cuts to extend cash runway, with estimated net savings of $3.8M in 2025 and up to $38M in 2026, aligning resources to key commercial and clinical milestones.
• Positive Sentiment: Q2 2025 revenue of $0.3M (including $0.1M from CIMVEST sales) vs. zero last year, and net loss narrowed to $37.7M from $56.7M in Q2 2024, reflecting early commercial traction and favorable non‐cash adjustments.

Presentation

[Operator]

Good morning, ladies and gentlemen, and welcome to the Humacyte Second Quarter twenty twenty five Results Conference Call. Currently, all participants are in a listen only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference is being recorded. I would now like to turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead.

[Tom Johnson, Director - Corporate Communications at LifeSci Advisors, LLC]

Thank you, operator. Before we proceed with the call, I'd like to remind everyone that certain statements during this call are forward looking statements under U. S. Federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.

[Tom Johnson, Director - Corporate Communications at LifeSci Advisors, LLC]

Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward looking statements, except as required by law. Information presented on this call is contained in the press release we issued this morning and in our Form 10 Q, which after the filing may be accessed from the Investor page of the Hemocyte website. Joining me today on today's call from Hemocyte are Doctor. Laura Nicholson, President and Chief Executive Officer Dale Sander, Chief Financial Officer and Chief Corporate Development Officer and BJ Schnazli, Chief Commercial Officer.

[Tom Johnson, Director - Corporate Communications at LifeSci Advisors, LLC]

Doctor. Nicholson will provide a summary of the company's progress for the quarter in recent weeks, and Dale will review the company's financial results for the quarter ended 06/30/2025. Following their prepared remarks, BJ will join Laura and Dale for a Q session. I'll now turn the call over to Doctor. Laura Nicholson. Go ahead, Laura.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Thank you, Tom. Good morning, everyone, and thank you for joining us for our second quarter twenty twenty five financial results and business update call. Following the landmark success of obtaining FDA approval of CIMVES for the treatment of extremity vascular trauma last year, we continue to execute on the commercial launch of this groundbreaking product. Progress during our second quarter and recent weeks was marked by continued expansion of our Value Analysis Committee, or VAC, approvals. This has led to a major expansion of the number of approvals that are now able to purchase CIMVEST.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Recently, we also announced that the US Defense Logistics Agency granted electronic catalog or ECAT listing approval to CIMVEST. Going along with this, we have recorded our first sale to a US military facility. We did encounter some headwinds during April and May due to unsubstantiated public attacks by certain detractors. However, we've seen an acceleration in VAC approval activity and commercial sales in June and July. Coupled with the continued advancement of our Acellular tissue engineered vessel or ATAP in our pipeline programs, we believe that we're positioned for growth and value generation in 2025 and beyond.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

During today's call, I'll review these developments in more detail, before turning the call over to Dale for a review of our financial results. D. J. Chesley, our Chief Commercial Officer, will then join us to help answer your questions. Beginning with our commercial launch of CIMVEST, we're pleased by the traction that we've continued to gain in our interactions with civilian hospitals.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

To date, a total of 13 organizations have completed the VAC process and have approved the purchase of SIMVEST. Because some of these VAC approvals include multi hospital networks, a total of 82 civilian hospitals are now eligible to purchase CIMVEST. This is an enormous increase from the five civilian hospitals that were eligible to purchase CIMVEST at our last quarterly earnings call. Furthermore, an additional 40 VAC sites are currently conducting reviews of CIMVEST, and we expect that the number of hospitals eligible to purchase CIMVEST will continue to grow. After VAC approval, contracting and negotiations with each individual hospital are completed before sales and shipment to that hospital can commence.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Currently, our sales team is actively targeting high volume centers, having back approval for contracting negotiations. July product sales of approximately 300,000.0 exceeded the total sales that we recorded for the first half of the year. Also in July, we announced that CIMVEST was awarded the Electronic Catalog, or ECAT, listing approval from the U. S. Defense Logistics Agency.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

ECAT is an Internet system that provides the Department of Defense and other federal agencies with access to manufacturers and distributors products. The ECAT approval makes CIMVEST available to healthcare professionals treating military service members, veterans, and other patients receiving care at approximately 35 military treatment facilities and approximately 160 U. S. Department of Veterans Affairs hospitals. With ECAT approval in place, it's not generally necessary to also obtain MAC approval at the military treatment facilities or VA sites.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Instead, purchases facilitated directly through the ECAT system. Since obtaining ECAT approval just a few weeks ago, we've already recorded our first commercial sale to a US military facility. This facility is a state of the art medical complex located on a major US military base and provides healthcare to approximately 200,000 active duty service personnel, retirees, their family members. Subsequent to the initial shipment, this facility has also reordered Cynbeth. We have great interest in improving the medical options that are available to healthcare professionals who are treating military personnel and their families, and we're actively advancing our discussions with additional military treatment facilities.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

In August, we were notified that the Centers for Medicare and Medicaid Services, or CMS, declined to approve our application for the New Technology Add on Payment, or NTAP, for CIMBEST. Our application was submitted in October 2024, and along with the majority of applications that were submitted to CMS this cycle, our application was also denied. The reason provided by CMS was that Timvest does not have a unique mechanism of action as compared to veins or synthetic grafts, and therefore did not qualify for their newness criterion. This conclusion was extremely surprising to us. We believe that the potential impact of the NTAP on our commercial success is fairly limited, because only about four point three percent of vascular trauma patients who are falling within our approved indication are covered under Medicare reimbursement.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Because private pay insurers are the most common source of reimbursement for vascular trauma patients that are falling within our indication, We're engaging in discussions with private payers about supplemental reimbursement for CIMVEST in the trauma indication. We believe that the results of our budget impact model, or BIM, which we published several months ago, along with our published clinical trial results, will encourage supplemental reimbursement from private payers. I'll now turn to the ATAF, a program which is our next priority, which is the dialysis access for patients with end stage kidney failure. We're pleased to see that results from our V07 Phase three trial were presented in a plenary session at the Society of Vascular Surgery Annual Meeting in June. The VO7 results presentation that was focused on patients at high risk of fistula non maturation was one of only three selected for special mention by the Society in their own announcement.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

The VO7 clinical trial enrolled a total of two forty two patients, of which one hundred and ten were considered to be at high risk of fistula non maturation. Among this high risk cohort, functional patency at six months and secondary patency at twelve months were significantly higher in ATEF recipients as compared with fistula. Duration of access usability over the first year was also significantly higher in the ATAF group at eight months versus only four and a half months for arteriovenous fistula with a p value of 0.00002. Results of the VO7 trial have also been accepted for presentation at the annual Kidney Week meeting for 2025 later this year. Women and men having diabetes and obesity make up more than half of the dialysis access market.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Patients with a high risk of fistula non maturation have historically been underserved by the current standard of care, since waiting for fistula maturation can result in prolonged catheter exposure, increased risk of infection, and additional procedures performed to assist in the maturation of the non functioning fistula. Because of these risks, patients with fistula non maturation have a high unmet medical need. We believe that the efficacy and safety results of the VO7 subgroup, combined with the approximately fifty percent fistula failure rate in this high risk group, means that this is an excellent population for us to target in the market. We look forward to publication of the results from the VO7 Phase three trial in a major peer reviewed medical journal later this year. After discussions with the FDA about a supplemental BLA filing in dialysis access, we're planning to target the general subgroup of patients at high risk official and non maturation.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Before we file a supplemental BLA, which we anticipate later in 2026, our plan is to complete the interim analysis of the currently ongoing V012 Phase III trial that's being conducted only in women and which compares the ATEVs to fistula for hemodialysis access. To date, a total of 100 patients have been enrolled in the V012 phase three trial, out of a target of approximately 150 patients. An interim analysis is planned when the first 80 patients reach one year follow-up, and this enrollment threshold was achieved in April 2025. Subject to these interim results, Humacyte's plan is to submit a supplemental BLA in the 2026, including data from VO12 and the VO7 phase three pivotal studies, to expand the CIMVEST label and add AV access for hemodialysis as an indication. We're pleased with the progress that we're making in 2025, and we look forward to sharing our progress with all of you as the rest of the year unfolds.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

With that, I'll now turn it over to Dale for a review of our financial results and other business developments.

[Dale Sander, CFO, Chief Corporate Development Officer & Treasurer at Humacyte]

Thank you, Laura. We reported $300,000 in revenue for the 2025, of which $100,000 related to U. S. Sales of Cymbet. The remaining $200,000 resulted from a research collaboration with a large medical technology company to evaluate the potential use of our bioengineered human tissue in specific cardiovascular and vascular applications.

[Dale Sander, CFO, Chief Corporate Development Officer & Treasurer at Humacyte]

Revenue for the six months ended 06/30/2025 was $800,000 of which $200,000 related to U. S. Sales of CymVest and $600,000 resulted from the research collaboration. There was no revenue for either the second quarter or the six months ended 06/30/2024. Cost of goods sold was $200,000 for the 2025 and $400,000 for the six months ended 06/30/2025 and included overhead related to unused production capacity, which was recorded as an expense in the period.

[Dale Sander, CFO, Chief Corporate Development Officer & Treasurer at Humacyte]

There was no cost of goods sold for either the 2024 or the six months ended 06/30/2024. As previously discussed, during the 2025, we implemented a plan to reduce our workforce by 30 employees, defer additional plan new hires and reduce other operating expenses. These cost reductions were made to extend our cash runway and to better align our organizational structure with our top business objectives. These reductions were made thoughtfully and we retained key personnel, resources and initiatives to meet our key corporate goals and milestones. These key objectives include the commercial launch of CIMVEST, including sales, marketing and manufacturing completion of the V012 Phase three pivotal study of the ATEF in dialysis and the planned filing of a supplemental BLA with the FDA in the dialysis indication and also the filing of an IND to commence human study of the small diameter ATEF in CABG.

[Dale Sander, CFO, Chief Corporate Development Officer & Treasurer at Humacyte]

We estimate that we have incurred and will incur aggregate charges representing one time cash expenditures for severance and other employee termination benefits of approximately $700,000 the majority of which was incurred during the 2025. We estimate net savings due to workforce reductions, operating cost reductions and reduced capital expenditures net of this termination severance and benefits totaling approximately $3,800,000 in 2025. Net savings are estimated to be up to approximately $38,000,000 in 2026 for a total estimated savings of over $50,000,000 in 2025 and 2026 relative to the original budget forecast. Due to the timing of the cost reduction plan, any anticipated savings are expected to occur after 06/30/2025. Research and development expenses were $22,000,000 for the 2025 compared to $23,800,000 for the 2024 and were $37,400,000 for the six months ended 06/30/2025 compared to $45,000,000 for the six months ended 06/30/2024.

[Dale Sander, CFO, Chief Corporate Development Officer & Treasurer at Humacyte]

The decrease in R and D expenses for the 2025 compared to 2024, primarily related to capitalization of overhead costs associated with the commercial manufacturing of CIMVIS offset by higher non commercial production runs. The decrease in R and D expenses for the six months ended 06/30/2025 compared to 2024 resulted primarily from decreased material costs as the company began capitalizing expenditures for inventory following the commercial launch of Invesque as well as the capitalization of overhead costs associated with this commercial manufacturing. Selling, general and administrative expenses were $7,800,000 for the 2025 compared to $5,700,000 for the 2024 and were $15,900,000 for the six months ended 06/30/2025 compared to $11,100,000 for the six months ended 06/30/2024. The increase in 2025 expenses compared to the prior year resulted primarily from The U. S.

[Dale Sander, CFO, Chief Corporate Development Officer & Treasurer at Humacyte]

Commercial launch of CymVest in the vascular trauma indication, including increased personnel expenses. Other net income or expense for the 2025 was a net expense of $7,900,000 compared to a net expense of $27,200,000 for the 2024 and other net income of $54,400,000 for the six months ended 06/30/2025 compared to other net expense of $32,500,000 for the six months ended 06/30/2024. The decrease in other net expense for the 2025 and the increase in other net income for the six months ended 06/30/2025 compared to prior year results resulted primarily from the noncash remeasurement of the contingent earn out liability associated with our August 2021 merger with Alpha Healthcare Acquisition Corp. Net loss was $37,700,000 for the 2025 compared to a net loss of $56,700,000 for the 2024. And net income was $1,500,000 for the six months ended 06/30/2025 compared to a net loss of $88,600,000 for the six months ended 06/30/2024.

[Dale Sander, CFO, Chief Corporate Development Officer & Treasurer at Humacyte]

The decrease in net loss for the 2025 and the increase in net income for the six months ended 06/30/2025 compared to prior year periods was primarily due to the non cash re measurement of the contingent earn out liability described above. We had cash, cash equivalents and restricted cash of $88,400,000 as of 06/30/2025. Total cash used was $6,900,000 for the six months of 2025 compared to net cash provided of $13,100,000 for the first six months of 2024. The net cash used for the first six months of 2025 included $46,700,000 in net proceeds from a public offering completed in March 2025. The total cash provided for the first six months of 2024 included $43,000,000 in net proceeds from a public offering completed in March 2024 and the receipt of $20,000,000 in proceeds from a draw under a loan arrangement that did not reoccur in 2025.

[Dale Sander, CFO, Chief Corporate Development Officer & Treasurer at Humacyte]

With that, I will turn it over to Laura for some closing remarks.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Thank you, Dale. The approval and launch of CIMVEST is a powerful example of our commitment to delivering truly transformative regenerative medicine solutions to improve patient outcomes. With our strong commercial execution, our promising pipelines, and our dedicated team, we're confident in our ability to continue making a positive impact. Thank you for joining our call today. And operator, we're now ready to take questions.

[Operator]

Thank Our first question comes from the line of Ryan Zimmerman with BTIG. Please proceed with your question.

[Ryan Zimmerman, MD & Medical Technology Analyst at BTIG]

Good morning. Thanks for taking our questions, Laura and Dale. Appreciate it. Maybe just to start on some of the dynamics commercially, Laura. If you think about second quarter volume versus what's taken place in July and you noted that uptick, has anything changed in your view that you think you can identify in July that now becomes kind of more part of your commercial strategy in terms of launching Cymba?

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Thank you for that Ryan. A lot of it is just passage of time. We really embarked on the VAC process in late February, early March and many of these committees just take months and months. So part of it was that. Part of the uptick in hospitals eligible to purchase CymVest was the fact that we did have several hospital systems approve of that product in their VAC process.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

But I would also say, we've looked at decreasing the price of CIMBEST from $29,500 to $24,250 This decrease in price still allows us to have good margins on the product, but by coming in below $25,000 this has increased the ease with which VAC committees can review our product and agree to bring it onto the shelf.

[Ryan Zimmerman, MD & Medical Technology Analyst at BTIG]

Yeah, actually that was my next question around pricing strategy, just looking at kind of the unit volumes versus the revenue. And is that now something that you're making standard across all facilities? Guess, how do we think about kind of your pricing strategy over time? If this is kind of the new price point that we should think about going forward?

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

I think this is the new price point that we should think about. This was a price point that we put into place in July 1. So that certainly corresponds, that had some overlap with the uptick in sales. I don't think that was the entire thing though, because we clearly had centers that were buying before the decrease in price. But the decrease in price, you know, will now be standard for the next year and then, just as with any other medical products, we will consider annual price increases on a yearly basis.

[Ryan Zimmerman, MD & Medical Technology Analyst at BTIG]

Okay, alright. Thanks for taking my questions. I'll hop back in queue.

[Operator]

Thank you. Our next question comes from the line of Josh Jennings with TD Cowen. Please proceed with your question.

[Josh Jennings, Managing Director at TD Cowen]

Hi. Good morning, Lorindale. Thanks for the I wanted to just ask, I know you talked about some of the headwinds early in the year from substantiated tax by detractors. And I was just wanted to review just the accrual of real world evidence and any registry data that would build over the coming quarters, years that would significantly bury any detractor noise?

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Well, think, you know, so as we've mentioned to the market, we do have some post approval commitments with the FDA to essentially create a registry of trauma patients and follow at least 100 patients for a year. We're still working on that protocol with the FDA, so that registry hasn't officially kicked off yet, but we're still, we're on time, we're meeting our timelines and our milestones for that. But I actually think that the real world evidence is going to continue to accrue in different hospitals that are using the product. Multiple hospitals have reordered the product and there are people who are using it with a tremendous amount of success. So I think that word-of-mouth, but also publications from real world use of the product will definitely to solidify our commercial position.

[BJ Scheessele, Chief Commercial Officer at Humacyte]

Josh, Was just going to jump in and add to what Laura was saying. Obviously, had published our budget impact model, but we continue to publish our trauma data, both civilian and military, be it The US and work in Ukraine. First, it was thirty year data, have upcoming one year data to continue to show the durability of our product.

[BJ Scheessele, Chief Commercial Officer at Humacyte]

I think that's important. And just to round out around the public attacks, how that has played out and it was somewhat to Ryan's point too, is that it's just really slowed the approval process. The majority of the fact is it's just now taking longer to get through hospitals, but have been able to overcome that. And I think that's also the tough economy has made it tougher for any new products. You talk to other companies that have launched new products recently, and it's just in general a longer process.

[BJ Scheessele, Chief Commercial Officer at Humacyte]

But given our full funnel and working through this process and the success that we had June and July, feel that we're turning the corner.

[Josh Jennings, Managing Director at TD Cowen]

Thanks for that. And wanted to touch on the inclusion on the electronic catalog and open up access to the 190 military treatment facilities. Any help just thinking through the commercial effort in this VA hospital channel to drive increased traction? I know you've had your first order but wanted to kind of get help thinking about back half of the year in this channel and then in 2026 and how you guys can go on offense more fully here.

[BJ Scheessele, Chief Commercial Officer at Humacyte]

Yeah, kind of how I look at it is, there's both the individual hospital work and then obviously collection of hospitals or some type of larger purchase. Here in the near term with the ECAD again opens up the military treatment facilities, I'd say a good number of them are targets of ours and then a much larger number of VAs, but it'll be more selective targets within the VAs where they obviously perform trauma procedures, so a minority of them. We've had the initial order, reorder, we've been able to meet with some of the other major facilities, some that were involved in our clinical work, others that we've had peer to peer discussion, those that have used it in the military introducing us to other hospital and surgeons. So I think through the rest of this year we'll be penetrating those hospitals, those hospitals of targets of ours. But then in parallel there is obviously the procurement process for some type of bulk purchase stockpiling that we are working in parallel and I believe as we have more successful military experience, that in concert with working the procurement process, as we end the year and roll into next year, the larger purchase becomes more viable for us.

[Josh Jennings, Managing Director at TD Cowen]

Thank you for that as well. And then just lastly, on AV access indication, you've secured the 80 patients enrolled for that back in April and have 100 today. Is it okay to kind of forecast enrollment completion for the trial for the 150 patients by year end 2025 and maybe just kind of review the timelines for interim analysis once you get the last patient follow-up, twelve month follow-up in April 2026 and how that could play out next year. Thanks for taking all the questions.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Yeah, Josh. So, we're going to aim to complete 150 patients by the end of the year. It's always hard to know, you know, it's very hard to predict trial enrollment. So, it could be before the end of the year, could be a little after the end of the year, hard to know. But regardless, the interim analysis is now fixed, as you mentioned, in April 2026.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

So, would imagine we will have top line results from that, know, it's certainly by May or June for that interim analysis. And then we would be able to share those results with the market. As far as the way the trial is designed, the way it was originally written is that if we are successful on the interim analysis, and if our vessel is superior to fistula with those 80 patients, then we're done. The trial is successful and we move on. In that situation, we would then, as we've said, anticipate filing a supplemental BLA in the 2026.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

If we don't hit that interim analysis, then we just continue following the 150 patients and we would feel pretty confident that we're gonna hit the analysis at 150. And since all of those patients would already have been enrolled, the additional time lag there would be, I don't know, six or eight months, something like that.

[Josh Jennings, Managing Director at TD Cowen]

Thanks for reviewing that Laura, appreciate it.

[Operator]

Thank you. Our next question comes from the line of RK with H. C. Wainwright. Please proceed with your question.

[Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC]

Thank you. Good morning, Laura and Dale. A couple of quick questions from me. The first question is, looking back at the first quarter press release, you were stating 45 hospitals had initiated the back process. So how many of those have actually ordered at this point?

[Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC]

And also, any insight into what the timeline is in general for getting through the VAC to the ordering process itself.

[BJ Scheessele, Chief Commercial Officer at Humacyte]

Laura, can jump on in on this.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Yeah, why don't you take that BJ? You'll be better.

[Tom Johnson, Director - Corporate Communications at LifeSci Advisors, LLC]

Yeah. Feel

[BJ Scheessele, Chief Commercial Officer at Humacyte]

free to add. So is a mix of hospitals that we started early and then hospitals that we've approached more recently, a mix of them that have worked through the process to then have the approval to then be able to sell into. But as we stated in the press release, we've had 12 hospitals to date order CIMVEST, and then a number of them actually already having reordered. So our success rate with VAC is strong. As I mentioned before, in Q2, some of the public attacks did slow us down with value analysis committees, that's where I was mentioning that in kind of from my commercial experience, you could think of three to six months to get through a value analysis committee and then obviously contracting on the back end.

[BJ Scheessele, Chief Commercial Officer at Humacyte]

We view that as six to nine plus months now. One, in general, because of the economy, but then also some of the attacks on us. But as I also mentioned, we have a full sales funnel and not all of them take the upper end and not all of them the lower end. So, you have a full funnel, you always have something coming through on the back end with approval and then be able to sell into. But that's something that we've accounted for and, as I mentioned, believe that we're turning the corner on.

[Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC]

Thank you for that. The second question is regarding the negative decision by the CMS. So what sort of an impact, if any, would it have on the private payers' reimbursement decisions?

[BJ Scheessele, Chief Commercial Officer at Humacyte]

Yeah, Laura can jump in on that one too and feel free. Sure.

[Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC]

As

[BJ Scheessele, Chief Commercial Officer at Humacyte]

Laura had mentioned, obviously, you know, a disappointment for us, newness, I think we can kind of all agree that our product new and a one of one type, we were denied, that was disappointing. There are pathways that we think you can refile, that's something that we will look at and consider. But when it rolls to and again private payers are the ones that pay the majority of these vascular trauma repair type of procedures in these patients. Hey, we believe that her product is new, but more importantly how private payers view, in essence, being able to pay for a product and writing procedures behind that is really based on your clinical and health economic data and so not only of what we've gathered but published peer reviewed both on the clinical side and following these patients over time and our budget impact model that is also published of reducing costly complications like infections and amputations versus products that are used today that private insurers will see this as a strong value proposition and work with them to get them to incrementally pay for our product.

[Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC]

Thanks for taking my questions.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Guess I would add to that RK that our success rate with Vax has been pretty good and we've gotten into it an enormous number of hospitals just in the last couple months, you know, up to 84, which is very exciting for us. But, you know, when hospitals look at the financial prospects for a product, they're really just looking at the puts and takes on that initial hospitalization because this is a DRG process and so hospitals are focused on the cost to take care of that patient just during the hospitalization. Payers on the other hand, are on the hook for longer term complications. So particularly with infection and amputation, which drive a lot of costs in the initial hospitalization, but which continue to drive costs after discharge because of readmissions, because of physical therapy, because of repeated procedures. Insurance companies are on the hook for all of that.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

And so I believe that financial case for providing a supplemental payment for CymVest and trauma is gonna be even stronger with private payers. So, we've got our ducks in a row. We're lining up private payers and we're gonna go out and start having those conversations very soon.

[Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC]

Thanks. Thank you both.

[Operator]

Thank you. Our next question comes from the line of Bruce Jackson with The Benchmark Company. Please proceed with your question.

[Bruce Jackson, Equity Research Analyst at The Benchmark Company LLC]

Hi, good morning and thank you for taking my question. I was wondering if we could get an update on the coronary artery bypass graft program.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Yes, absolutely. We have a paper that's been accepted for publication about our primate results in coronary artery bypass that we expect to publish in the near future, and we'll put out a press release with that when that happens. We're also making excellent headway on our IND filing with the FDA. So we're in the process of pulling that filing together and we expect to have that in later in 2025, as we've messaged the market previously. After we submit the IND, we anticipate that the FDA will spend some time looking at it.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

We're a first in class product and we're going into the human coronary system, so we expect that there will be some review time, but once they approve that, and I certainly anticipate that they will, then we would start our clinical trial sometime in 2026. So, everything is on track with what we've messaged the market previously.

[Bruce Jackson, Equity Research Analyst at The Benchmark Company LLC]

Okay, great. Thank you. That's it for me.

[Operator]

Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Doctor. Niklasic for any final comments.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

Thank you everyone for joining us this morning. Our fantastic commercial team has continued to execute during this exciting time. I personally am very excited by the fact that so many hospitals and both civilian and military treatment facilities and VAs are now eligible to purchase our product, more than 200 facilities. If we compare that to the five facilities that were on tap to purchase our product just three months ago, I think this is huge progress. So, we're going to continue working on the contract negotiations and continue shipping and selling product.

[Laura Niklason, Founder, President, CEO & Director at Humacyte]

It's make product, sell product. That's where our focus is and I'm so glad that we're getting traction here. So I appreciate your time and I look forward to sharing more results with you later this year.

[Operator]

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

Participants

Executives

• Laura Niklason, Founder, President, CEO & Director
• Dale Sander, CFO, Chief Corporate Development Officer & Treasurer
• BJ Scheessele, Chief Commercial Officer

Analysts

• Tom Johnson, Director - Corporate Communications at LifeSci Advisors, LLC
• Ryan Zimmerman, MD & Medical Technology Analyst at BTIG
• Josh Jennings, Managing Director at TD Cowen
• Ramakanth Swayampakula, MD & Senior Healthcare Analyst at H.C. Wainwright & Co., LLC
• Bruce Jackson, Equity Research Analyst at The Benchmark Company LLC